Safety of 3-FL (3-Fucosyllactose) as a novel food pursuant to Regulation (EU) 2015/2283

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http://hdl.handle.net/10138/340735

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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) , Turck , D & Heinonen , M 2021 , ' Safety of 3-FL (3-Fucosyllactose) as a novel food pursuant to Regulation (EU) 2015/2283 ' , EFSA Journal , vol. 19 , no. 6 , 6662 . https://doi.org/10.2903/j.efsa.2021.6662

Title: Safety of 3-FL (3-Fucosyllactose) as a novel food pursuant to Regulation (EU) 2015/2283
Author: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck, Dominique; Heinonen, Marina
Contributor organization: Department of Food and Nutrition
Helsinki One Health (HOH)
Food Quality & Safety
Date: 2021-06
Language: eng
Number of pages: 25
Belongs to series: EFSA Journal
ISSN: 2314-9396
DOI: https://doi.org/10.2903/j.efsa.2021.6662
URI: http://hdl.handle.net/10138/340735
Abstract: Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3-FL but also contains D-lactose and its monomers, L-fucose and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli K-12. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population, except for food supplements for which the target population is individuals above 1 year of age. The anticipated daily intake of 3-FL from the NF at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake of 3-FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. In infants below 1 year of age, a possible exceedance of a natural intake was observed, but the degree of this exceedance is not considered of safety concern in view of the wide range of 3-FL concentrations in human milk. Food supplements are not intended to be used if other foods with the added NF (as well as human milk for young children) are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Subject: 3-Fucosyllactose
3-FL
human milk oligosaccharide
HMO
HiMO
novel food
safety
HUMAN-MILK OLIGOSACCHARIDES
C-13-LABELED OLIGOSACCHARIDES
URINARY-EXCRETION
INFANTS URINE
LACTOSE
416 Food Science
Peer reviewed: Yes
Rights: cc_by_nd
Usage restriction: openAccess
Self-archived version: publishedVersion


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